Our regulatory specialists excel not only in regulatory document preparation and project management but also in facilitating health authority engagement. We ensure comprehensive support throughout the regulatory process. This includes expert advice tailored to optimize product development and lifecycle maintenance.
Consumer Health
Regulatory Consultancy
ClinChoice’s regulatory team offers comprehensive support across various stages of clinical development and regulatory processes.
- Strategic regulatory consulting services
- Regulatory gap analysis, review, and remediation
- Product development processes
- Regulatory positions for new therapies
- Requests for scientific advice from regulatory bodies
- Approval strategies for regulatory compliance
- Independent due diligence and scientific regulatory reviews
- Regulatory approval processes for orphan drug designations
- Support with institutional review board or ethics committee documentation
- Regulatory advice for import/export permits and labeling
- Regulatory submission strategies
Global Regulatory Support
In the US, our regulatory specialists collaborate with clients to streamline product entry, ensuring compliance with FDA regulations for products and successful completion of approvals for applications. ClinChoice handles investigational applications, emphasizing compliance with the eCTD format. In Europe, we work closely with various National Competent Authorities (NCAs) to ensure the quality, safety, and efficacy of medicines, ATMPs, and medical devices throughout clinical development.
Regulatory Services
ClinChoice diligently detects and monitors changes, keeping a vigilant eye on regulatory developments. This proactive approach provides clients with timely communication, keeping them abreast of the latest regulatory updates. The team’s effectiveness is amplified by a comprehensive regulatory database, ensuring information is current and easily accessible. We provide expert guidance and advice in the following areas:
- US agent and regulatory liaison
- Reparation support for FDA meetings
- Research and commercial IND maintenance
- ANDA, NDA, and BLA submissions
- MAA and IMPD submissions
- User fee payment management
- Drug establishment registration and listing
Country-Specific Requirements
ClinChoice delivers extensive assistance for clinical projects through its Clinical Studies Submissions Database (CSSD), which encompasses study requirements and procedures for medicinal products. Our regulatory intelligence professionals guarantee compliance with regional and local requirements by accessing, summarizing, and assessing global regulatory intelligence. Additionally, we consult on country-specific legislation, establish liaisons with authorities and committees, and tailor regulatory training to ensure a holistic approach to regulatory compliance.